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SPEctral CT and miRna In Acute Myocardial Infarction for Comprehensive Adverse Remodeling Evaluation

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Acute myocardial infarction with ST-segment elevation (STEMI) remains a leading cause of morbidity and mortality worldwide. Although advances in reperfusion therapy have reduced early mortality, many patients later develop adverse ventricular remodeling (AVR), which increases the risk of heart failure and cardiovascular death. Current imaging methods, such as echocardiography and cardiac magnetic resonance (CMR), provide valuable prognostic information but have limitations in availability, cost, and their ability to predict AVR early and individually. Spectral computed tomography (CT) is an emerging imaging technique that can characterize myocardial tissue, quantify infarct size, assess microvascular obstruction, and detect complications, with lower contrast and radiation requirements compared to conventional CT. In parallel, circulating microRNAs (miRNAs) have been identified as stable and non-invasive biomarkers that reflect key biological processes in post-infarction remodeling. Several miRNAs are linked to fibrosis, apoptosis, and ventricular remodeling, suggesting their potential to complement imaging findings in risk prediction. This study proposes a multicenter, prospective cohort of patients with STEMI and reduced left ventricular function to evaluate whether combining spectral CT tissue characterization with serum miRNA profiling can improve early prediction of AVR. The main objective is to generate and validate a multiparametric prognostic model integrating imaging and molecular biomarkers to identify high-risk patients who may benefit from closer monitoring and tailored therapeutic strategies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults ≥18 years.

• First STEMI treated with primary PCI.

• Left ventricular ejection fraction (LVEF) ≤45% during index hospitalization.

• Ability to provide informed consent.

Locations
Other Locations
Spain
Hospital La Princesa
RECRUITING
Madrid
Hospital Ramón y Cajal
RECRUITING
Madrid
Complejo Asistencial Universitario de Salamanca
RECRUITING
Salamanca
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Contact Information
Primary
Candelas Pérez del Villar, MD in Cardiology
mcperezvi@saludcastillayleon.es
+34923291200
Backup
Beatriz Martín Carro, PhD
bmartincar.ibsal@saludcastillayleon.es
+34923291200
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2028-12
Participants
Target number of participants: 95
Treatments
Active_comparator: Control group
At the coordinating center (CAUSA), a control group (n = 20) will be included, consisting of patients with a clinical indication for cardiac CT for reasons other than myocardial infarction, meeting the following criteria: absence of myocardial injury or structural heart disease, ≤1 cardiovascular risk factor, LVEF \> 55%, and no significant valvular disease (grade \< III).
Experimental: Adult patients experiencing a first ST-segment elevation myocardial infarction (STEMI)
Patientes will be included in this group if the following requirements are met:~Hospital admission due to STEMI, treated in accordance with current clinical practice guidelines.~Left ventricular systolic dysfunction, defined as a left ventricular ejection fraction (LVEF) \< 50%, assessed by transthoracic echocardiography (TTE) within the first 24-72 hours of admission.~Provision of signed informed consent.
Related Therapeutic Areas
Sponsors
Collaborators: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Leads: Instituto de Investigación Biomédica de Salamanca

This content was sourced from clinicaltrials.gov